The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: comfilcon A
Device: Synergi
Device: Biotrue
Other: stenfilcon A

Registration Number: NCT02510820

Lead Sponsor: Coopervision, Inc.

Brief Summary: This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

Inclusion Criteria

They are of legal age and capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive)
They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.
At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They currently use silicone hydrogel soft contact lenses.
They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).

Exclusion Criteria

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or lactating.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Synergi / comfilcon A	comfilcon A	Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
Synergi / comfilcon A	stenfilcon A	Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
Synergi / comfilcon A	Synergi	Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
Biotrue / comfilcon A	comfilcon A	Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
Biotrue / comfilcon A	Biotrue	Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
Biotrue / comfilcon A	stenfilcon A	Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.

Primary Outcome Measures

Name	Time	Method
Conjunctival Hyperaemia	Baseline, 1 week, 2 weeks, 4 weeks	Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Limbal Hyperaemia	Baseline, 1 week, 2 weeks, 4 weeks	Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Corneal Staining	Baseline, 1 week, 2 weeks, 4 weeks	Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.
Papillary Conjunctivitis	Baseline, 1 week, 2 weeks, 4 weeks	Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Comfort	4 weeks	Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Vision	4 weeks	Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Ocular Redness	1 week, 2 weeks, 4 weeks	Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.
Ease of Lens Insertion	1 week, 2 weeks, 4 weeks	Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.
Dryness	1 week, 2 weeks, 4 weeks	Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.
Burning/Stinging	1 week, 2 weeks, 4 weeks	Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.
Ease of Lens Removal	1 week, 2 weeks, 4 weeks	Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.
Ease of Use of Solution	1 week, 2 weeks, 4 weeks	Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy
Overall Score	1 week, 2 weeks, 4 weeks	Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.